Modify the Approved Study
The sequence of IRB activities for your study
APPLY for IRB approval
MODIFY the approved study ←
RENEW your IRB approval
REPORT events and new information
CLOSE your IRB application
What you should have already completed
- Determining that a Modification to your application is required. Modifications to exempt studies are only necessary if they might invalidate the exemption determination. The document GUIDANCE Exempt Research provides more detail. Replacing a study team member doesn’t require a Modification unless the replaced person is the lead researcher (PI). Some events that were reported as Modifications in HSD’s old paper process are now submitted as Reports of New Information.
- The IRB review of any already submitted modifications must be completed before you can submit another modification (except changes to the Study Team, which are not reviewed by the IRB as “modifications” and which can be submitted at any time).
Required skills and tools
- The same as for APPLY.
- Use of “track changes” in Word documents is essential for creating Modification applications.
The parts of your Modification application
|Your existing IRB application required
This includes the IRB Protocol form, the Zipline SmartForms, other study documents, etc. Any new or revised study-specific documents required
Some common examples:
There is no Modification form that must be uploaded to Zipline
What to do: The first step
Identify which existing uploaded documents must be changed in order to describe your modification(s). Example: adding a new procedure will likely require you to add a description of the new procedure to your IRB Protocol form and to your study consent form.
What to do: Other steps
- Revise the documents you identified in Step 1, using track changes for Word documents. The best way to do this is to go into Zipline, download the documents from the Documents Tab, save them to your computer, and then make the changes with track changes turned on. Accept any old tracked changes before adding new changes. Be sure to update the date and/or version of each document.
- Prepare any new study documents for uploading.
- Create any documents that do not already exist. For example, you might need to create a new study consent form for a new study population.
- Label new documents with a title, date and version number. A footer in the document is usually the best place for this information.
- Give each electronic document a unique and descriptive name to help distinguish them in Zipline.
- Create an electronic version of any new paper documents by scanning them as a PDF.
- Create the Zipline part of your application. Log into Zipline and navigate to the study you want to modify. Click on Modify Study. Answer the questions. As you go through the SmartForms, replace uploaded documents with the revised versions you prepared.
- Check your application for completeness, by using the Hide/Show Errors activity.
- Submit your application to HSD. Click on Submit then click on OK.
What to expect after submitting
An HSD staff member will be assigned to your application, usually within one business day. You will receive an email notice if additional information is needed and also to inform you about the outcome of the IRB’s review. The ongoing status of your modification is displayed in the workflow graphic at the top of the modification workspace in Zipline.
Three common, high-impact mistakes (and how to prevent them)
- Incomplete revision – that is, not identifying all of the parts and sections of your application that need to be revised because of your proposed study modification. Common examples: not revising all appropriate questions in the Procedures part of the IRB Protocol form, and not revising the Confidentiality section of the IRB Protocol form.
Prevention: Read through all parts of your entire existing application, to identify the parts and questions where you will need to make revisions.
- Not updating the date and/or version number of documents. This can result in significant confusion about whether you are using the correct consent forms.
Prevention: Be sure to update the date and version number on each uploaded document.
- Uploading the revised documents to the wrong place in Zipline. This may require HSD staff to send the application back to you so that you can move the documents to the correct location; HSD staff are not able to to this for you.
Prevention: Click “Upload Revision” to REPLACE existing documents with revised documents instead of adding them. Zipline will permanently retain the original documents and forms on the History tab.